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Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects (SHT)

Primary Purpose

Congenital Heart Disease, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Kambiz Norozi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring congenital heart disease, smart mobile technology, children, adolescents, lifestyle counselling, nutrition, physical activity

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • overweight or obese (BMI> 85%) patients
  • between 7-17 years of age
  • operated or non-operated congenital heart disease
  • reside in Southwestern Ontario

Exclusion Criteria:

  • inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
  • involvement in any concurrent lifestyle intervention program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lifestyle intervention

    Arm Description

    Participants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.

    Outcomes

    Primary Outcome Measures

    Change in Baseline Body Mass Index (BMI) at 1 year
    BMI is derived from body mass divided by the square of the body height
    Change in Baseline Fat Mass at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure fat mass.
    Change in Baseline Lean Mass at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure lean mass.
    Change in Baseline Percent Fat at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure percent fat.
    Change in Baseline Percent Android Fat at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.
    Change in Baseline Visceral Adipose Tissue at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.
    Change in Baseline Bone Mineral Content at 1 year
    Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.
    Change in Baseline Maximum Oxygen Consumption at 1 year
    Maximal exercise graded treadmill test will determine maximal oxygen consumption.

    Secondary Outcome Measures

    Change in Baseline Average Caloric Intake at 1 year
    Average caloric intake is estimated from three-day food records.
    Change in Baseline Self-Report Physical Activity Levels at 1 year
    Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children
    Change in Baseline Physical Activity Levels at 1 year
    Physical activity levels will be measured from accelerometers
    Change in Baseline Quality of Life at 1 year
    Pediatric Quality of Life Inventory Generic Core Scales
    Change in Baseline Muscle function at 1 year
    Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.
    Change in Baseline Electrocardiographic measurement at 1 year
    Electrocardiogram
    Change in Baseline Transthoracic echocardiographic measurement at 1 year
    Echo-cardiogram will be employed.
    Change in Baseline Endothelial vasodilator function at 1 year
    Peripheral arterial tonometry will assess endothelial vasodilator function.
    Change in Baseline Lipid Profile at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Electrolytes at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Creatinine at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Urea at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Fasting Glucose at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Serum Insulin at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Change in Baseline Adiponectin at 1 year
    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Full Information

    First Posted
    November 24, 2016
    Last Updated
    December 20, 2016
    Sponsor
    Kambiz Norozi
    Collaborators
    London Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02980393
    Brief Title
    Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects
    Acronym
    SHT
    Official Title
    The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kambiz Norozi
    Collaborators
    London Health Sciences Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease, Pediatric Obesity
    Keywords
    congenital heart disease, smart mobile technology, children, adolescents, lifestyle counselling, nutrition, physical activity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle intervention
    Arm Type
    Experimental
    Arm Description
    Participants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle intervention
    Intervention Description
    The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
    Primary Outcome Measure Information:
    Title
    Change in Baseline Body Mass Index (BMI) at 1 year
    Description
    BMI is derived from body mass divided by the square of the body height
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Fat Mass at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure fat mass.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Lean Mass at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure lean mass.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Percent Fat at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure percent fat.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Percent Android Fat at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Visceral Adipose Tissue at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Bone Mineral Content at 1 year
    Description
    Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Maximum Oxygen Consumption at 1 year
    Description
    Maximal exercise graded treadmill test will determine maximal oxygen consumption.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Secondary Outcome Measure Information:
    Title
    Change in Baseline Average Caloric Intake at 1 year
    Description
    Average caloric intake is estimated from three-day food records.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Self-Report Physical Activity Levels at 1 year
    Description
    Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Physical Activity Levels at 1 year
    Description
    Physical activity levels will be measured from accelerometers
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Quality of Life at 1 year
    Description
    Pediatric Quality of Life Inventory Generic Core Scales
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Muscle function at 1 year
    Description
    Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Electrocardiographic measurement at 1 year
    Description
    Electrocardiogram
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Transthoracic echocardiographic measurement at 1 year
    Description
    Echo-cardiogram will be employed.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Endothelial vasodilator function at 1 year
    Description
    Peripheral arterial tonometry will assess endothelial vasodilator function.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Lipid Profile at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Electrolytes at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Creatinine at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Urea at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Fasting Glucose at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Serum Insulin at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
    Title
    Change in Baseline Adiponectin at 1 year
    Description
    Blood is drawn from patients who have been asked to fast for at least 10 hours.
    Time Frame
    This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: overweight or obese (BMI> 85%) patients between 7-17 years of age operated or non-operated congenital heart disease reside in Southwestern Ontario Exclusion Criteria: inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition involvement in any concurrent lifestyle intervention program
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kambiz Norozi, MD, PhD
    Organizational Affiliation
    London Health Science Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29167745
    Citation
    Rombeek M, De Jesus S, Altamirano-Diaz L, Welisch E, Prapavessis H, Seabrook JA, Norozi K. The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial. Pilot Feasibility Stud. 2017 Nov 15;3:59. doi: 10.1186/s40814-017-0207-y. eCollection 2017.
    Results Reference
    derived

    Learn more about this trial

    Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects

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